| Primary Device ID | 18032568861273 |
| NIH Device Record Key | 400dcad4-ff47-466a-9ce3-fb18e71f7bf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROCALLUS FIXATOR |
| Version Model Number | 1 |
| Catalog Number | 90046 |
| Company DUNS | 438793622 |
| Company Name | ORTHOFIX SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18032568861273 [Primary] |
| JDW | Pin, Fixation, Threaded |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
[18032568861273]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-24 |
| 18053504367055 | PROCALLUS FIXATOR HYBRID CONNECTION |
| 18053504360902 | DISTAL HUMERAL CLAMP |
| 18032937168057 | ARTICULATED BODY FOR HEMICALLOTASIS |
| 18032568867268 | PROCALLUS SYSTEM STERIBOX, EMPTY |
| 18032568867251 | PROCALLUS SYSTEM WITH ACTUATOR STERIBOX, EMPTY |
| 18032568867244 | PROCALLUS SYSTEM INSTRUMENT STERIBOX, EMPTY |
| 18032568866599 | SUPPLEMENTARY SCREW HOLDER CLAMP |
| 18032568861303 | ELBOW EXTENDED RANGE CLAMP |
| 18032568861273 | RADIOLUCENT ANKLE CLAMP |
| 18032568861266 | ARTICULATION LOCKING NUT FOR RADIOLUCENT ANKLE CLAMP |
| 18032568861242 | SELF-ALIGNING ARTICULATED BODY FOR PROCALLUS |
| 18032568861235 | SELF-ALIGN ARTIC BODY ASSEMBLY KIT FOR PROCALLUS |
| 18032568861228 | CENTRAL BODY FEMALE COMPONENT FOR SHORT PROCALLUS |
| 18032568861211 | CENTRAL BODY MALE COMPONENT FOR SHORT PROCALLUS |
| 18032568861204 | PROCALLUS SHORT ACTUATOR EXTENDS TO 2.75 CM |
| 18032568861198 | PROCALLUS SHORT CENTRAL BODY |
| 18032568861181 | PROCALLUS SHORT FIXATOR KIT WITH ACTUATOR |
| 18032568861174 | PROCALLUS SHORT FIXATOR KIT |
| 18032568861167 | ARTICULATED BODY FOR THE HIP FOR PROCALLUS |
| 18032568861150 | CENTRAL BODY FEMALE COMPONENT FOR LONG PROCALLUS |
| 18032568861143 | CENTRAL BODY MALE COMPONENT FOR LONG PROCALLUS |
| 18032568861136 | CENTRAL BODY FEMALE COMPONENT FOR STANDARD PROCALLUS |
| 18032568861129 | CENTRAL BODY MALE COMPONENT FOR STANDARD PROCALLUS |
| 18032568861112 | CENTRAL BODY LOCKING NUT FOR PROCALLUS |
| 18032568861105 | MICROMOVEMENT LOCKING NUT FOR PROCALLUS |
| 18032568861099 | PROCALLUS CLAMP SCREW |
| 18032568861082 | PROCALLUS LONG ACTUATOR EXTENDS TO 8 CM |
| 18032568861068 | PROCALLUS T-CLAMP |
| 18032568861051 | PROCALLUS STRAIGHT CLAMP |
| 18032568861044 | BUSH |
| 18032568861037 | PROCALLUS LONG BODY |
| 18032568861020 | PROCALLUS STANDARD BODY |
| 18032568861013 | PROCALLUS LONG FIXATOR KIT WITH ACTUATOR |
| 18032568861006 | PROCALLUS LONG FIXATOR KIT |
| 18032568860993 | PROCALLUS STANDARD FIXATOR KIT WITH ACTUATOR |
| 18032568860986 | PROCALLUS STANDARD FIXATOR KIT |
| 18032568032703 | RADIOLUCENT ANKLE PIN GUIDE |
| 18032568032567 | PROCALLUS ASSEMBLY KIT |
| 18032568032550 | TORBAY-GARCHES CLAMP TEMPLATE RADIOLUCENT |
| 18032568032505 | METAPHYSEAL CLAMP TEMPLATE |
| 18032568032475 | ANGLED CLAMP TEMPLATE |
| 18032568032352 | DRILL GUIDE DIAMETER 4.8 MM LENGTH 140 MM |
| 18032568032345 | SCREW GUIDE LENGTH 160 MM |
| 18032568030624 | TORBAY-GARCHES CLAMP |
| 18032568030556 | CLAMP COVER FOR ANGLED CLAMP |
| 18032568030549 | METAPHYSEAL CLAMP |
| 18032568030518 | ANGLED CLAMP |
| 18053504369844 | Spare part, not medical device, not for sale. Reported for registration of UDI direct marking. |
| 18053504369783 | Spare part, not medical device, not for sale. Reported for registration of UDI direct marking. |
| 18053504369776 | Spare part, not medical device, not for sale. Reported for registration of UDI direct marking. |